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NCT05747794 · ClinicalTrials.gov registry record · Phase 2
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy
A Phase 2 study of Breast Carcinoma, sponsored by Immutep S.A.S..
- Active
- Registry status
- Phase 2
- Development phase
- 849
- Enrollment target
- 20
- Study locations
NCT05747794: Active Phase 2 study of Breast Carcinoma, sponsored by Immutep S.A.S..
NCT05747794 is a Phase 2 study of Breast Carcinoma that is active but no longer recruiting, run by Immutep S.A.S.. The registered enrollment target is 849 participants, above the 762-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05747794, a Phase 2 study of Breast Carcinoma, is active but no longer recruiting, sponsored by Immutep S.A.S..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 849 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy? * Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Primary Outcome
Primary endpoint for Phase 3 portion, secondary endpoint for Phase 2 lead-in portion
Conditions Studied
Interventions
- DRUG Paclitaxel
- OTHER placebo
- BIOLOGICAL eftilagimod alpha
Study Locations (20)
Other
- AZ Sint-Jan Brugge Oostende av - Bruges
- Cliniques Universitaires Saint-Luc - Brussels
- Grand Hopital de Charleroi - Hopital Notre Dame - Charleroi
- Universitair Ziekenhuizen Antwerpen - Edegem
- Centre Hospitalier de l'Ardenne - Libramont
- Clinique Saint-Pierre- Ottignies - Ottignies-Louvain-la-Neuve
- ARENSIA Exploratory Medicine LLC - Tbilisi
- ARENSIA Exploratory Medicine Phase I Unit - Chisinau
- Institut Català d'Oncologia - Badalona
- VHIO - Hospital Vall d'Hebron - Barcelona
- Hospital Clinic de Barcelona - Barcelona
- Parc Taulí Hospital Universitari - Barcelona
- Hospital Universitario Reina Sofia - Córdoba
- Hospital Universitario de Jaén - Jaén
- Unidad Ensayos Clínicos Oncología Fundació IRB Lleida - Lleida
Texas
- Oncology Consultants - Houston
- The University of Texas MD Anderson Cancer Center - Houston
California
- The Oncology Institute - Whittier
District of Columbia
- The George Washington University Cancer Center - Washington D.C.
South Carolina
- Carolina Blood and Cancer Care Associates - Rock Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 849 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05747794 still lists
NCT05747794 is an interventional study that assigns participants to a tested intervention. The registered 849 participants enrollment target is mid-sized for trials with a published cap, above the 762-participant average among 106 other Breast Carcinoma trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT05747794 names 20 study sites across 5 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05747794 about?
NCT05747794 is a clinical study titled "Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy". The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of eft...
What is the current status of trial NCT05747794?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 849 participants. The study started on 2023-05-22. Estimated completion is 2027-07-31.
What conditions does trial NCT05747794 study?
This clinical trial studies the following conditions: Breast Carcinoma.
What interventions are being tested in trial NCT05747794?
The interventions under investigation include: Paclitaxel (DRUG), placebo (OTHER), eftilagimod alpha (BIOLOGICAL).
Who is sponsoring clinical trial NCT05747794?
This trial is sponsored by Immutep S.A.S., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05747794 being conducted?
This trial has 20 study locations across California, District of Columbia, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05747794's enrollment target sits among peer trials
849 15th of 106 higher than 92 of 106 other Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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